510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061459Substantially Equivalent

Tranquil Tri-Bte

General Hearing Instruments, Inc., New Orleans LA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K061459 is the FDA 510(k) clearance record for TRANQUIL TRI-BTE, a class II device, cleared for General Hearing Instruments, Inc. on under FDA product code KLW (Masker, Tinnitus). FDA records list 5 510(k) clearances for General Hearing Instruments, Inc., from to . As of , FDA records show no recalls naming K061459.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KLW Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
General Hearing Instruments, Inc. P.O. Box 23748, New Orleans LA
510(k) summary
Statement
Third party review
No

Clearances, product code KLW

Trailing 12 months
2 clearances under product code KLW in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260